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| 발행년 : | 2013 |
|---|---|
| 구분 : | 국외학술지 |
| 학술지명 : | NATURE REVIEWS DRUG DISCOVERY |
| 관련링크 : | http://www.riss.kr/link?id=O62107684 |
[자료 문의 : lib@nibp.kr / http://riss.kr 에서 직접 원문 복사 신청 가능, 관련링크 참고]
The risks of risk aversion in drug regulation
제어번호 62107684
저자명 Eichler, H. G. , Bloechl-Daum, B. , Brasseur, D. , Breckenridge, A. , Leufkens, H. , Raine, J. , SalmonsonT. , Schneider, C. K. , Rasi, G.
학술지명 NATURE REVIEWS DRUG DISCOVERY
권호사항 Vol.12 No.12 [2013]
발행처 Nature Publishing Group
자료유형 학술저널
수록면 907-916 [※수록면이 p5 이하이면, Review, Columns, Editor's Note, Abstract 등일 경우가 있습니다.]
ISSN 1474-1776
언어 eng
발행년도 2013년
등재정보 SCI;SCIE;SCOPUS
http://www.riss.kr/link?id=O62107684
Abstract
Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.
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